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Cohort Multiple Randomized Controlled Trials Open-Label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients-Tocilizumab Trial - CORIMUNO-TOCI-1
Contribution To Literature:
Among patients with moderate to severe COVID-19 pneumonia not needing ICU support in the CORIMUNO-TOCI-1 trial, tocilizumab did not reduce WHO-CPS scores at day 4.
Description:
The goal of the trial was to assess the safety and efficacy of tocilizumab among patients with moderate to severe coronavirus disease 2019 (COVID-19) pneumonia.
Study Design
Patients were randomized in a 1:1 fashion to either tocilizumab (n = 64) or usual care (n = 67). Usual care (antibiotic agents, antiviral agents, corticosteroids, vasopressor support, anticoagulants) was provided at the discretion of the clinicians. Tocilizumab was administered intravenously (IV) at 8 mg/kg on day 1. Administration of an additional fixed dose, 400 mg IV, on day 3 could be given if oxygen requirement had not decreased by >50%.
- Total number of enrollees: 131
- Duration of follow-up: 28 days
- Mean patient age: 64 years
- Percentage female: 32%
Inclusion criteria:
- Confirmed SARS-CoV-2 infection (positive on rRT-PCR and/or typical chest computed tomographic [CT] scan) with moderate, severe, or critical pneumonia (O2 >3 L/min), World Health Organization 10-point Clinical Progression Scale (WHO-CPS) score ≥5
- O2 levels of 3 L/min or higher but without noninvasive ventilation or mechanical ventilation
Exclusion criteria:
- Known hypersensitivity to tocilizumab
- Pregnancy
- Current documented bacterial infection
- Patients with any of following laboratory results out of the ranges detailed below at screening: Absolute neutrophil count 1.0 × 109/L or less or platelets <50 G /L
Other salient features/characteristics:
- Time from symptom onset to randomization: 10 days
- Cardiac history: 32%
- Median oxygen requirement: 5 L/min
Principal Findings:
The primary outcome, proportion of patients dead or needing noninvasive or mechanical ventilation on day 14 (>5 on the WHO-CPS), for tocilizumab vs. control, was 19% vs. 28% (hazard ratio 0.58, 95% credible interval, 0.30-1.11).
Secondary outcomes for tocilizumab vs. control:
- Death or mechanical ventilation at day 14: 17% vs. 27%
- 28-day survival: 89% vs. 88%
Interpretation:
The results of this trial indicate that among patients with moderate to severe COVID-19 pneumonia requiring oxygen but not ICU care, tocilizumab did not reduce WHO-CPS scores lower than 5 at day 4 but might have reduced the risk of noninvasive ventilation, mechanical ventilation, or death by day 14. No difference on day 28 mortality was found.
Longer-term data are awaited. This trial is small but adds to the overall literature on therapeutic options for COVID-19 management. Tocilizumab is an anti–human interleukin-6 receptor (IL-6R) monoclonal antibody that inhibits IL-6 signaling by binding soluble IL-6R and membrane IL-6R and is approved for rheumatoid arthritis, juvenile inflammatory arthritis, and refractory giant cell arteritis.
References:
Hermine O, Mariette X, Tharaux PL, et al., on behalf of the CORIMUNO-19 Collaborative Group. Effect of Tocilizumab vs Usual Care in Adults Hospitalized With COVID-19 and Moderate or Severe Pneumonia: A Randomized Clinical Trial. JAMA Intern Med 2020;Oct 20:[Epub ahead of print].
Editorial: Parr JB. Time to Reassess Tocilizumab’s Role in COVID-19 Pneumonia. JAMA Intern Med 2020;Oct 20:[Epub ahead of print].
Clinical Topics: COVID-19 Hub, Noninvasive Imaging, Prevention, Computed Tomography, Nuclear Imaging
Keywords: Coronavirus, COVID-19, Immunotoxins, Noninvasive Ventilation, Pneumonia, Primary Prevention, Receptors, Interleukin, Respiration, Artificial, Reverse Transcriptase Polymerase Chain Reaction, Severe Acute Respiratory Syndrome, severe acute respiratory syndrome coronavirus 2, Tomography, X-Ray Computed
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